Medical seals are used to cap the port of an IV bag or other medical container after the contents of the container have been modified by a pharmacist or other technician. IV containers generally contain conventional liquid solutions, such as dextrose, sodium chloride, etc., to which the pharmacist adds a drug or solution as prescribed by the physician. The pharmacist first selects an IV bag having the appropriate solution therein, and removes the original seal that seals the injection port. This procedure is carried out in a sterile environment so as not to contaminate either the contents of the IV bag, the membrane of the port or the sterile surface of the medical seal. The drug is generally added by filling a syringe with the drug, inserting the syringe needle into the sterile, self-sealing rubber membrane covering the injection port, and injecting the drug into the solution in the IV bag. A medical seal is then removed from a carrier strip pulled from a dispenser box, and the sterile side of the seal is applied over the injection membrane. Medical seals are generally constructed with tear slits so that when removed from the port of a medical container, telltale pieces of the seal remain on the port to provide a nurse or other attendant an indication that the IV bag may have been tampered with, such as by an unauthorized or inadvertent injection of a fluid into the bag.
Medical seals are manufactured with many features to facilitate the identification of the drug injected into the IV bag, to detect tampering of the seal, and to assist the attendant in the application and removal thereof from the injection port of the medical container. Various medical seals are disclosed in U.S. Pat. Nos. 4,266,687 by Cummings; 4,390,104 by Cummings; 4,423,819 by Cummings; 4,514,248 by Cummings; 4,527,703 by Cummings and 4,598,834 by Singletary.
A medical seal is generally constructed using a foil/plastic laminate seal member that is adhesively attached to a release liner formed on one side of a long carrier strip. Each seal includes an adhesive surface surrounding a sterile adhesive-free area. The sterile adhesive-free area is placed into contact with the injection membrane of the IV container, and the surrounding adhesive is adapted for attaching the seal around the port. Many individual seals are attached to a carrier liner so as to be dispensed one at a time. The strip of medical seals is wound around an annular core, usually 1,000 seals per roll. The roll of seals undergoes a process in which the seals are sterilized, including the adhesive surface and the adhesive-free area. Once the adhesive-free area is sterilized, it remains sterilized until removed from the carrier liner prior to being placed on the injection membrane of the IV container. Thus, the sterility of the procedure is not compromised, which would otherwise allow bacteria and other particles to contaminate the injection membrane or the contents of the IV bag.
The dispensing of the individual seals is carried out in such a manner so as to maintain the original sterility thereof. If a seal is dispensed from the roll and not used immediately thereafter to seal the injection port of a medical container, then it must be discarded. In the event that a portion of a seal is inadvertently lifted from the carrier strip and not immediately used, then it must also be discarded. The partial lifting of a seal from the carrier strip may prematurely occur when the carrier strip is pulled around the outlet corner of the dispenser box in which the roll of seals is stored, or the roll is inadvertently spun inside the box when the carrier strip is pulled too fast, in which event a length of the carrier strip will unwind inside the dispenser box. The unwinding of the carrier strip inside the dispenser box can allow portions of the seals to be prematurely lifted from the carrier strip.
The core on which the roll of seals is wound is made from various materials, primarily paper or plastic. Although the core is specified to be a certain diameter, such as three inches in diameter, the actual diameter of the core often varies plus or minus several thousandths of an inch, with paper cores having the widest variance. The variance in the core diameter causes some rolls to be tight when placed on a core holder located in the dispenser box. The tight fit between the core of the carrier strip roll and the core holder makes it difficult to pull the strip out of the dispenser box and dispense the seals from the strip. When the core of the roll of seals is slightly oversized and fits loosely on the core holder of the dispenser, the roll of seals will spool or rotate freely on the core holder, thus tending to tangle the strip of seals inside the dispenser box.
Conventional seal dispensers include a plastic insert that holds a roll of seals inside a paper/chipboard folding carton or box. The roll of seals is placed onto the core holder and the end of the carrier strip is routed over the exit hump formed on the plastic insert, and then routed through a small slit in the edge of the dispenser box. The plastic insert, with the roll of seals thereon, is inserted into the dispenser box. The lid of the box is then taped shut. The exit hump formed on the plastic insert is intended to provide a gentle curved path over which the carrier strip is pulled. This exit structure is intended to eliminate the sharp exit corner which would otherwise allow the seals to prematurely lift off of the carrier strip when the strip is pulled out of the box around the sharp corner of the box itself.
If the roll of seals inside the dispenser box spins or spools excessively when dispensing, loops in the carrier strip are created inside the dispenser box and the inadvertent lifting of the seal from the carrier strip can occur. When a technician pulls down too quickly on the carrier strip during dispensing of seals from the box, or with too great a force, the roll of seals can continue to spin on the core holder of the dispenser. As noted above, when the roll of seals spools or spins inside the dispense box, an excess length of the carrier strip is unrolled inside the dispenser box. This can cause folding or bending of the carrier strip inside the dispenser box to a degree that one or more of the seals can prematurely lift off of the release liner of the carrier strip, thus allowing the sterile target area of the seal to be exposed.
Problems and limitations with the standard dispenser box include the following. First, the plastic insert tends to slide and move around in the dispenser box during dispensing, and moves away from the sharp corner of the box near the small exit slit. This movement permits the position of the exit hump on the insert to move away from the slit in the box and allow the carrier strip to be pulled at such a sharp angle that allows the seals to prematurely lift off the carrier strip and expose the sterile area on the seals to contaminants. Secondly, the dispenser box needs to be positioned by the user so that the carrier strip pulled from the box exits from the bottom of the box to prevent premature lifting of the seals off the carrier strip. Thirdly, the plastic insert and core holder formed thereon are often slightly too large in diameter for some rolls, and too small for other rolls. Thus, a smooth rolling motion of the core on the plastic insert, with a small amount of drag, is not obtained, whereupon the carrier strip must be pulled with an excessive force, or the roll of seals spins too freely. Fourth, the entire dispenser requires assembly of the folding carton and insertion of plastic insert and roll of seals therein.
From the foregoing, it can be seen that a need exists for a medical seal dispenser that overcomes the foregoing, and other problems and shortcomings. A need exists for a medical seal dispenser where the plastic insert and the container box are integrated together to make the product more cost effective, and to prevent relative movement between such components. Another need exists for a medical seal dispenser that is constructed as a unitary item, and opens like a clamshell to allow easy insertion of the roll of seals therein, and then snap locks together. Another need exists for a medical dispenser that includes a core holder adapted for manually adjusting the amount of drag on the core, as a function of the particular inside diameter of the core. Another need exists for a medical seal dispenser that is easily constructed and reliable in operation.